TY - JOUR
T1 - Catalysing the development and introduction of paediatric drug formulations for children living with HIV
T2 - a new global collaborative framework for action
AU - Penazzato, Martina
AU - Watkins, Melynda
AU - Morin, Sébastien
AU - Lewis, Linda
AU - Pascual, Fernando
AU - Vicari, Marissa
AU - Lee, Janice
AU - Hargreaves, Sally
AU - Doherty, Meg
AU - Siberry, George K.
N1 - Funding Information:
We thank all the experts involved in the formal and informal consultations that have informed the development of the Global Accelerator for Paediatric Formulations. Technical expertise for this report was supported in part by the US President's Emergency Plan for AIDS Relief. The findings and conclusions of this Viewpoint are those of the authors and do not necessarily represent the official positions of the US Government or WHO.
Publisher Copyright:
© 2018 World Health Organization. Published by Elsevier Ltd/Inc/BV. All rights reserved.
PY - 2018/5
Y1 - 2018/5
N2 - Progress in the development and introduction of paediatric formulations for key infectious diseases is poor in low-income and middle-income countries (LMICs). Although major steps have been made in the scale-up of antiretroviral medicines in LMICs, the development and deployment of formulations for infants and children is suboptimal. Of the children living with HIV globally (most in Africa), only 43% are receiving antiretroviral therapy (ART), many with suboptimal formulations. These shortfalls pose a series of challenges to meeting global treatment targets of 1·6 million children (aged 0–14 years) on ART by the end of 2018 (95% coverage) and to ensuring that 95% of those on ART are virologically suppressed. The Global Accelerator for Paediatric Formulations (GAP-f) has been developed to accelerate research, development, regulatory filing, introduction, and uptake of prioritised paediatric antiretrovirals in age-appropriate formulations by 2020, with innovative, strategic, and sustainable financing. The GAP-f will build on existing efforts to maximise coordination and alignment of policy makers, research networks, regulatory agencies, funding organisations, and manufacturers in paediatric HIV and other paediatric diseases, including tuberculosis, viral hepatitis, and other infectious diseases. Paediatric drug development and scale-up will require special efforts to bring greater visibility and new solutions to ensure that children in LMICs have access to effective and appropriate treatment options.
AB - Progress in the development and introduction of paediatric formulations for key infectious diseases is poor in low-income and middle-income countries (LMICs). Although major steps have been made in the scale-up of antiretroviral medicines in LMICs, the development and deployment of formulations for infants and children is suboptimal. Of the children living with HIV globally (most in Africa), only 43% are receiving antiretroviral therapy (ART), many with suboptimal formulations. These shortfalls pose a series of challenges to meeting global treatment targets of 1·6 million children (aged 0–14 years) on ART by the end of 2018 (95% coverage) and to ensuring that 95% of those on ART are virologically suppressed. The Global Accelerator for Paediatric Formulations (GAP-f) has been developed to accelerate research, development, regulatory filing, introduction, and uptake of prioritised paediatric antiretrovirals in age-appropriate formulations by 2020, with innovative, strategic, and sustainable financing. The GAP-f will build on existing efforts to maximise coordination and alignment of policy makers, research networks, regulatory agencies, funding organisations, and manufacturers in paediatric HIV and other paediatric diseases, including tuberculosis, viral hepatitis, and other infectious diseases. Paediatric drug development and scale-up will require special efforts to bring greater visibility and new solutions to ensure that children in LMICs have access to effective and appropriate treatment options.
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U2 - 10.1016/S2352-3018(18)30005-5
DO - 10.1016/S2352-3018(18)30005-5
M3 - Comment/debate
C2 - 29739700
AN - SCOPUS:85046756696
SN - 2352-3018
VL - 5
SP - e259-e264
JO - The Lancet HIV
JF - The Lancet HIV
IS - 5
ER -